Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer (Superhero)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Not yet enrolling; Phase 2

Conditions: Colon Cancer Stage III

Treatments: Drug: Dostarlimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06830239

S68882

2024-512499-36-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. This investigational medicinal product (IMP) has been approved by the Belgian authorities, but not for the treatment of colon cancer.

It is known that a small number of patients with pMMR/MSS colon cancer may have significant response to medication of this type (immunotherapy) depending on each person's biology.

Trial intervention for all patients will be neo-adjuvant dostarlimab 500 mg IV, given alone by intravenous infusion. Two administrations of dostarlimab are foreseen, at three weeks interval, before surgery for your colon cancer. It has not yet been proven that this treatment can cure, improve or stabilise your disease or condition.

The study aims to investigate specific molecular changes in tumour and blood after dostarlimab monotherapy administered and before surgery which could be associated with improved response to conventional treatment in some patients. If you decide to participate, as the duration of treatment with dostarlimab is 6 weeks, surgery may be slightly delayed compared to patients that are not treated with dostarlimab and go directly for surgery. It remains uncertain if this is beneficial in your personal situation but some patients might experience significant response. The risks have been carefully assessed and the potential benefits for some patients are considered important and justify undertaking the treatment.

Subsequent therapy after surgery remains at the discretion of the treating physician.

The duration of a patient on trial will last up to 4 months from the first dose of dostarlimab and afterwards 2 years of follow up is applicable.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years of age and capable of giving informed consent
• primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III
• tumour expresses an MMR proficient/microsatellite stable called MSS
• tissue samples from tumour and colon mucosa available for molecular analyses
• capable of receiving immunotherapy
• adequate general health status and organ function (blood tests)

Exclusion criteria

• no prior cancer treatment
• not pregnant and using effective contraception if applicable

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Dostarlimab monotherapy

Experimental group

Description:

Dostarlimab should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes at a dose of 500 mg once every 3 weeks (Q3W), for 2 cycles (6 weeks in total).

Treatment:

Drug: Dostarlimab